Press Release
China Medical System: New Drug Application for Vitiligo Indication of Ruxolitinib Phosphate Cream Accepted in China
SHENZHEN, CHINA – China Medical System Holdings Limited (the “Company”, together with its subsidiaries, the “Group” or “CMS”) is pleased to announce that on September 24, 2024, the New Drug Application (NDA) for vitiligo indication of ruxolitinib phosphate cream (the “ruxolitinib cream” or the “Product”) has been accepted by the National Medical Products Administration of China (NMPA). This is another substantial milestone for ruxolitinib cream in China, following the approval for Urgent Clinical Import by Hainan Medical Products Administration and approval for marketing in Macau for vitiligo, and it is also a key step in benefiting over ten million of patients with vitiligo in China.
Ruxolitinib cream achieved positive results in Chinese Real-World Study. The primary efficacy endpoint was the proportion of patients in the treatment group who achieved F-VASI 75 response at week 24, which was 49.5%, significantly higher than the target value of 14.1% (p<0.0001). The study met its primary endpoint, demonstrating that ruxolitinib cream is effective in treating patients with nonsegmental vitiligo, reducing the area of the lesions, and repigmenting the skin. All secondary efficacy endpoints showed a trend of benefit consistent with the primary efficacy endpoint, and the treatment effect for vitiligo continued to improve with longer treatment duration. Adverse events mostly had severity levels of grade 1 or 2. No adverse event (AE) leading to discontinuation or withdrawal, and no serious adverse event (SAE) related to the study drug occurred.
While advancing the process of NDA for the Product, the Group is conducting the transfer of ruxolitinib cream from overseas production to domestic production (localization technology transfer), which is being orderly promoted by the Contract Development Manufacturing Outsourcing Organization (CDMO), and the lab-scale and pilot trial studies have been completed and under scale-up production. The Group strives to complete the localization study as soon as possible, register in Mainland China and obtain marketing approval, so as to enable the Chinese patients with vitiligo to use the innovative product.
Vitiligo is a chronic autoimmune disease characterized by depigmentation of the skin, which results from the loss of pigment-producing cells known as melanocytes. It is estimated that there are approximately 14 million vitiligo patients in China[1]. Non-segmental vitiligo patients account for approximately 85% of them. Topical corticosteroids (TCS) and calcineurin inhibitors (CI) are used off-label for non-segmental vitiligo, however, these therapies have clinical deficiencies with long-term adverse reactions of long-term treatment or limited efficacy[2、3]. If the Product being successfully approved for marketing in China, it will be the first prescription drug approved for repigmentaton in vitiligo in Mainland China, bringing novel treatment hopes for Chinese vitiligo patients.
CMS has always adhered to its mission of providing competitive products and services to meet unmet medical needs. Guided by innovation strategy, the Group continuously strengthens its independent R&D as well as external collaboration, enriching its product pipelines. Looking ahead, CMS will continue to identify products with differentiated advantages globally and efficiently promote their clinical development and commercialization, bringing more novel and effective drugs to patients.
About ruxolitinib cream
Ruxolitinib cream, (Opzelura), a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, and is the first and only treatment for repigmentation approved for use in the United States[4]. Ruxolitinib cream (Opzelura) is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable[5]. In Europe, ruxolitinib cream (Opzelura) is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age[6].
The Product is not approved by the NMPA for any indication in Mainland China. However, on 12 August 2023, the Product was approved by Hainan Medical Products Administration for Urgent Clinical Import, and officially became available to applicable patients in the Hainan Boao Lecheng International Medical Tourism Pilot Zone (the “Pilot Zone”) on August 18, for the topical treatment of non-segmental vitiligo in adults and adolescents aged 12 and above with facial involvement. Benefiting from the Early and Pilot Implementation Policy granted by the state to Hainan Free Trade Port and the Pilot Zone, patients with vitiligo in China can apply for the Product in Boao Super Hospital first and receive treatment from the expert team. In addition, ruxolitinib cream was approved by the Pharmaceutical Administration Bureau (ISAF) of Macau on 11 April 2024 for the topical treatment of non-segmental vitiligo with facial involvement in adult and adolescents form 12 years of age.
On 2 December 2022, the Group through a subsidiary of the Company, a dermatology medical aesthetic company (“CMS Skinhealth”) entered into a Collaboration and License Agreement (the “License Agreement”) with Incyte for topical formulations of ruxolitinib for the treatment of autoimmune and inflammatory dermatology diseases. In accordance with the License Agreement, the Group through CMS Skinhealth received an exclusive license to develop, register and commercialize the Product in Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, Taiwan Region and eleven Southeast Asian countries (Indonesia, Philippines, Vietnam, Thailand, Myanmar, Malaysia, Cambodia, Laos, Singapore, Timor-Leste and Brunei Darussalam) (the “Territory”) and a non-exclusive license to manufacture the Product in the Territory. The License Agreement commenced on its effective date and has a royalty term of ten years from the date of the commercial sale of the Product in the Territory (the “Royalty Term”). Upon the expiration of the Royalty Term, the License Agreement may be renewed for a period of ten years thereafter (the “Initial Extended Royalty Term”) as per certain conditions defined in the License Agreement. Upon the expiration of the Initial Extended Royalty Term, the License Agreement may be extended for a period otherwise agreed by both sides as per certain conditions defined in the License Agreement.
Incyte has worldwide rights for the development and commercialization of the Product, marketed in the United States and Europe as Opzelura®. Opzelura and the Opzelura logo are registered trademarks of Incyte.
About CMS
CMS is a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, dedicated to providing competitive products and services to meet unmet medical needs.
CMS focuses on the global first-in-class (FIC) and best-in-class (BIC) innovative products, and efficiently promotes the clinical research, development and commercialization of innovative products, enabling the continuous transformation of scientific research into clinical practices to benefit patients.
CMS deeply engages in several specialty therapeutic fields, and has developed proven commercialization capabilities, extensive networks and expert resources, resulting in leading academic and market positions for its major marketed products. CMS continues to promote the in-depth development of its advantageous specialty fields and expand business boundaries. While strengthening the competitiveness of the cardio-cerebrovascular/gastroenterology business, CMS independently operates its dermatology and medical aesthetics business, and ophthalmology business, aiming to gain leading positions in specialty therapeutic fields, whilst enhancing the scale and efficiency. At the same time, CMS has expanded its business territory to the Southeast Asian market, striving to become a “bridgehead” for global pharmaceutical companies to enter the Southeast Asian market, further escorting the sustainable and healthy development of the Group.
Reference：
- Ezzedine K, Eleftheriadou V, Whitton M, van Geel N. Vitiligo. Lancet. 2015;386(9988):74-84. doi:10.1016/S0140-6736(14)60763-7
- Consensus on the diagnosis and treatment of vitiligo (2021 version)
- Kubelis-López DE, Zapata-Salazar NA, Said-Fernández SL, Sánchez-Domínguez CN, Salinas-Santander MA, Martínez-Rodríguez HG, Vázquez-Martínez OT, Wollina U, Lotti T, Ocampo-Candiani J. Updates and new medical treatments for vitiligo (Review). Exp Ther Med. 2021 Aug;22(2):797. doi: 10.3892/etm.2021.10229. Epub 2021 May 25. PMID: 34093753; PMCID: PMC8170669.
- Drug approval information can be found on the FDA official website, as follows: https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-topical-t…
- Drug approval information can be found on the Incyte official website, as follows: https://investor.incyte.com/news-releases/news-release-details/incyte-an…
- Drug approval information can be found on the EMA official website, as follows: https://www.ema.europa.eu/en/medicines/human/EPAR/opzelura
CMS Disclaimer and Forward-Looking Statements
This press release is not intended to promote any products to you and is not for advertising purposes. This press release does not recommend any drugs, medical devices and/or indications. If you want to know more about the diagnosis and treatment of specific diseases, please follow the opinions or guidance of your doctor or other medical and health professionals. Any treatment-related decisions made by healthcare professionals should be based on the patient’s specific circumstances and in accordance with the drug package insert.
This press release which has been prepared by CMS does not constitute any offer or invitation to purchase or subscribe for any securities, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. This press release has been prepared by CMS based on information and data which it considers reliable, but CMS makes no representation or warranty, express or implied, whatsoever, and no reliance shall be placed on, the truth, accuracy, completeness, fairness and reasonableness of the contents of this press release. Certain matters discussed in this press release may contain statements regarding the Group’s market opportunity and business prospects that are individually and collectively forward-looking statements. Such forward-looking statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and assumptions that are difficult to predict. Any forward-looking statements and projections made by third parties included in this press release are not adopted by the Group and the Company is not responsible for such third-party statements and projections.
Media Contact
Brand: China Medical System Holdings Ltd.
Contact: CMS Investor Relations
Website: https://web.cms.net.cn/en/home/
Source: China Medical System Holdings Ltd.
About Author
Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.
United States, 17th Oct 2024, – Yijin Hardware, a key player in precision CNC machining, has announced the global expansion of its sheet metal fabrication services. This development is aimed at supporting industries worldwide with high-quality, custom-engineered metal components. By extending services to new markets, Yijin Hardware strengthens its position as a reliable manufacturing partner for sectors that require precise, durable parts, such as automotive, aerospace, and electronics.
Yijin Hardware has a long history of providing precision-engineered components, and its expansion into international markets reflects the company’s response to rising demand for reliable sheet metal fabrication services. The new offerings will include laser cutting, metal bending, welding, and a variety of other fabrication processes, designed to accommodate a wide range of industrial applications.
“Precision and quality have always been at the heart of Yijin Hardware’s operations,” said Gavin Yi, CEO of Yijin Hardware. “The expansion of sheet metal fabrication services is a natural progression in the company’s growth, enabling access to more industries worldwide that require high-performance metal components for their operations.”
The sheet metal fabrication sector has seen increasing demand as industries move towards more complex and custom-engineered solutions. Yijin Hardware’s global expansion is positioned to meet these growing needs by offering scalable services that are capable of handling both small-scale production and larger manufacturing runs. The company’s advanced facilities are equipped with the latest machinery, ensuring that each part meets precise specifications and high-quality standards.
Yijin Hardware has also invested heavily in upgrading its production infrastructure to support the increased demand from international clients. Enhancements in laser cutting, welding, and assembly operations have been key factors in enabling the company to offer a more diverse set of services globally. The ability to handle custom and high-volume orders without compromising on quality is a cornerstone of Yijin Hardware’s service offerings.
“Looking ahead, Yijin Hardware is committed to further advancing its manufacturing capabilities,” Gavin Yi added. “There are plans to introduce more cutting-edge technologies that will enhance both CNC machining and sheet metal fabrication services. These advancements will ensure the company remains well-positioned to address the evolving needs of industries in the future.”
Yijin Hardware’s expanded services will cater to industries with a need for complex, high-precision components, including automotive parts, aerospace structures, and electronic enclosures. With a focus on maintaining strict quality control throughout the production process, the company aims to provide solutions that meet exacting industry standards.
As part of its expansion strategy, Yijin Hardware continues to emphasize innovation and efficiency. These principles are expected to guide the company’s future developments as it explores new manufacturing technologies and methods. The expansion also supports the company’s vision of being a global leader in precision engineering.
For further information about sheet metal fabrication services, please contact Yijin Hardware at +1 626 263 5841 or via email at yijing@yijinsolution.com.
Media Contact
Organization: Yijin Hardware
Contact
Person: Gavin Yi
Website:
http://yijinsolution.com/
Email:
yijing@yijinsolution.com
Country:United States
The post Yijin Hardware Delivers High-Quality Sheet Metal Fabrication Services Worldwide appeared first on
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United States, 17th Oct 2024, – Yijin Hardware, a well-established provider of custom CNC machining services, has announced its expansion into global markets. The company, recognized for its precision manufacturing capabilities, aims to support international businesses in industries such as aerospace, automotive, electronics, and medical with tailored CNC solutions. This move comes as industries worldwide increasingly require high-quality, custom-manufactured components to meet modern production needs.
Yijin Hardware’s decision to extend its services beyond China reflects its commitment to addressing the needs of a broader range of industries. With years of experience in CNC machining, the company has developed a reputation for delivering reliable and precise parts to a diverse set of clients. The expansion will provide industries worldwide with access to Yijin Hardware’s capabilities, backed by advanced technology and stringent quality control.
Gavin Yi, CEO of Yijin Hardware, commented on the expansion: “This move into international markets represents a significant milestone. Yijin Hardware has always emphasized precision and reliability, and this expansion allows those same standards to be brought to clients around the world. Whether the project involves a small batch of components or a large production run, the company is prepared to meet the exacting standards required by global industries.”
Operating from its facilities in Shenzhen, Yijin Hardware manages the full lifecycle of production, from initial design to final inspection. This comprehensive approach ensures that each project is carefully monitored to meet specific client requirements. Yijin Hardware’s ability to offer customized machining solutions is seen as a key factor in its growth, particularly as companies increasingly seek specialized components for complex applications.
Previously focused primarily on the domestic market in China, Yijin Hardware’s expansion aims to deliver the same level of precision and service to international clients. By positioning itself as a global CNC machining provider, the company plans to strengthen relationships with existing partners while establishing new connections in other regions.
This global expansion comes at a time when demand for CNC machining services is rising due to the increasing complexity of product designs and the need for enhanced precision in manufacturing. As industries continue to evolve, CNC machining remains crucial to ensuring that parts meet exact specifications. Yijin Hardware has embraced this role through continuous investment in advanced equipment and machining techniques.
Looking ahead, Yijin Hardware is also focused on the future of manufacturing and its impact on sustainability. The company plans to explore new methods that reduce material waste and promote more efficient production processes. According to Gavin Yi, “As the company expands globally, attention is focused not only on immediate goals but also on contributing to long-term sustainable manufacturing. CNC machining plays a critical role in reducing waste and improving production efficiency. Yijin Hardware is committed to finding ways to make processes more environmentally friendly, to become a leader in both precision and sustainability.”
Yijin Hardware’s entry into global markets signals a broader shift in its strategy, focusing on serving a more diverse range of industries with its expertise in CNC machining. By offering international clients access to its advanced manufacturing solutions, the company aims to become a trusted partner for businesses looking to streamline production with high-quality, custom-manufactured parts.
For more information about Yijin Hardware’s global CNC machining China, inquiries can be directed via phone at +1 626 263 5841 or by email at yijing@yijinsolution.com.
Media Contact
Organization: Yijin Hardware
Contact
Person: Gavin Yi
Website:
http://yijinsolution.com/
Email:
yijing@yijinsolution.com
Contact Number: 16262635841
Country:United States
The post Yijin Hardware Offers Global CNC Machining Services from China appeared first on
Brand News 24.
It is provided by a third-party content
provider. Brand News 24 makes no
warranties or representations in connection with it.
About Author
Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.
Since 1978, Catoctin Veterinary Clinic has been the trusted name in veterinary care for pets in Leesburg, VA, and surrounding Loudoun County. With over four decades of service, the clinic has established itself as a premier provider of comprehensive pet healthcare, offering services that cover a broad range of pet needs—from routine wellness exams to advanced surgical interventions.
Led by a team of experienced veterinarians and supported by a dedicated staff, Catoctin Veterinary Clinic’s commitment to ensuring the health and happiness of pets remains unmatched. Voted Best Veterinary Practice in Loudoun County in 2021, 2022, 2023, and 2024, the clinic continues to set the standard for veterinary excellence.
Comprehensive Wellness and Preventative Care
The cornerstone of Catoctin Veterinary Clinic’s offerings is its commitment to wellness exams and preventative medicine, providing regular health checkups to monitor the overall well-being of pets. These essential exams allow the clinic’s veterinarians to detect early signs of potential health concerns, ensuring timely interventions that help prevent future complications. The team also stresses the importance of vaccinations, flea and tick prevention, and heartworm care as part of a long-term health strategy.
By educating pet owners and promoting preventive care measures, Catoctin Veterinary Clinic helps pet parents take proactive steps to enhance their pets’ quality of life.
Advanced Diagnostic and Treatment Services
To complement its focus on preventive care, Catoctin Veterinary Clinic offers digital radiology and ultrasound services. These advanced diagnostic tools allow veterinarians to obtain high-resolution images that help diagnose a wide array of medical conditions. With this technology, pets receive precise and timely treatments, ensuring they recover quickly and return to a healthy lifestyle.
Surgical services are another key aspect of the clinic’s offerings. The team provides safe, effective surgical procedures using state-of-the-art equipment in a sterile environment. From routine spays and neuters to more complex surgical procedures, the clinic’s veterinarians perform each surgery with the utmost care and attention to detail.
Dental Care for Pets
Oral health is critical to overall well-being, and Catoctin Veterinary Clinic offers specialized dental care to maintain and improve pets’ oral hygiene. The clinic provides thorough dental exams, cleanings, and treatments to prevent conditions like periodontal disease, which can have serious effects on a pet’s overall health. The team educates pet owners on proper dental care practices, helping to ensure that pets live healthy, comfortable lives.
Geriatric and End-of-Life Care
Understanding that the needs of pets change as they age, Catoctin Veterinary Clinic is proud to offer geriatric care services to senior pets. Through a combination of wellness exams, nutritional counseling, and regular monitoring, the clinic provides comprehensive care tailored to the needs of aging pets, helping to manage conditions like arthritis, diabetes, and cognitive dysfunction.
Additionally, end-of-life care services are offered with compassion and sensitivity. The team supports pet owners during this difficult time, offering humane and respectful euthanasia services when the time comes to say goodbye to a beloved companion. Catoctin Veterinary Clinic’s goal is to ensure that pets live out their golden years in comfort and dignity, and that they pass with peace and grace when the time comes.
Client Education and Community Involvement
Catoctin Veterinary Clinic places a strong emphasis on client education, recognizing that informed pet owners are essential to the long-term health of their pets. The team regularly shares valuable insights on pet care through educational materials, consultations, and one-on-one discussions during visits. This proactive approach empowers pet parents to take a more active role in their pets’ health and well-being.
The clinic is also deeply committed to giving back to the community. Through various initiatives and partnerships, Catoctin Veterinary Clinic actively participates in local events and supports organizations that promote animal welfare in Loudoun County.
Convenient Access and Online Services
Catoctin Veterinary Clinic makes it easy for pet owners to access the care their pets need. Located at 112 Dry Mill Road SW, Leesburg, VA, the clinic offers convenient hours, including weekend availability, to accommodate busy pet owners. In addition to in-person services, the clinic provides a comprehensive online pharmacy, allowing clients to order medications, supplements, and food for their pets from the comfort of their homes.
For added convenience, the clinic offers CareCredit, a healthcare credit card that allows pet owners to manage out-of-pocket expenses with flexible payment options.
About Catoctin Veterinary Clinic
Founded in 1978, Catoctin Veterinary Clinic has grown to become a leading veterinary practice in Leesburg, VA, and Loudoun County. With a team of highly trained veterinarians and support staff, the clinic is dedicated to providing compassionate, high-quality care to pets and their owners. The clinic offers a full range of services, including wellness exams, surgical procedures, dental care, diagnostic services, and geriatric care.
Media Contact
- Address: 112 Dry Mill Road SW, Leesburg, VA 20175
- Phone: (703) 777-8447
- Website: www.catoctinvetclinic.com
Media Contact
Organization: Catoctin Veterinary Clinic
Contact Person: Paige Blumer
Website: http://catoctinvetclinic.com/
Email: Send Email
Contact Number: +17037778447
Address: 112 Dry Mill Road , Leesburg VA 20175
Country: United States
Release Id: 18102418656
The post Catoctin Veterinary Clinic Continues to Provide Exceptional Care to Leesburg, VA Pets appeared on King Newswire. It is provided by a third-party content provider. King Newswire makes no warranties or representations in connection with it.
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Disclaimer: The views, suggestions, and opinions expressed here are the sole responsibility of the experts. No Digi Observer journalist was involved in the writing and production of this article.
Yijin Hardware Delivers High-Quality Sheet Metal Fabrication Services Worldwide
Yijin Hardware Offers Global CNC Machining Services from China
Catoctin Veterinary Clinic Continues to Provide Exceptional Care to Leesburg, VA Pets
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